THE PATENT TERM RESTORATION ACT OF 1981-S. 255 HEARING BEFORE THE COMMITTEE ON THE JUDICIARY UNITED STATES SENATE NINETY-SEVENTH CONGRESS FIRST SESSION ON S. 255 A BILL TO AMEND THE PATENT LAW TO RESTORE THE TERM 81-860 O APRIL 30, 1981 Serial No. J-97-21 Printed for the use of the Committee on the Judiciary STANFORD GOV'T U.S. GOVERNMENT PRINTING OFFICE WASHINGTON: 1981 UNIVERSITY MAR 1982 DOCUMENT DEPARTMENT CIS RECORD ONLY: CONTENTS PROPOSED LEGISLATION S. 255-A bill to amend the patent law to restore the term of the patent grant for the period of time that nonpatent regulatory requirements prevent the marketing of a patented product Agency view from the Department of Health and Human Services STATEMENTS OF COMMITTEE MEMBERS CHRONOLOGICAL LIST OF WITNESSES Engman, Lewis A., president, Pharmaceutical Manufacturers Association..... Sarett, Dr. Lewis H., senior vice president for Science and Technology, Merck & Co., Inc.; accompanied by Rudolph J. Anderson, associate general counsel and director of patents, Merck & Co., Inc.; Arthur A. Smith, Jr., general counsel, Office of Sponsored Programs, Massachusetts Institute of Technol- ogy; and Edwin T. Yates, Ph. D., Office of Patent Management, Johns Reding, Nicholas, group vice president, Monsanto Co., and chairman of the board of directors, National Agricultural Chemicals Association; accompa- nied by Dr. Jack Early, president, National Agricultural Chemicals Associ- ation; Dr. Albert C. Zettlemoyer, president, American Chemical Society, accompanied by Dr. Willard Marcy, immediate past chairman, Committee on Patents and Related Matters, American Chemical Society; and Thomas A. Duerden, chairman of the board and chief executive officer, Electro- Biology, Inc., appearing for Health Industry Manufacturers Association ........ Larsen, Kenneth N., chairman, Generic Pharmaceutical Industry Association, president, Zenith Laboratories, Inc.; William F. Haddad, member of the board of directors, Generic Pharmaceutical Industry Association; and Sidney M. Wolfe, M.D., director, Public Citizen Health Research Group, accompanied by Benjamin Gordon, staff economist. Grabowski, Dr. Henry, professor of Economics, Duke University, and Thomas D. Kiley, vice president and general counsel, Genentech, Inc "Substitution Laws and Innovation in the Pharmaceutical Industry”. "Innovation and Invention-Consumer Protection Regulation in Ethical 33 U.S. pharmaceutical R. & D. expenditures as a percentage of U.S. pharmaceu- APPENDIX A The following interested organizations responded to a question submitted by Senator Grassley: Pharmaceutical Manufacturers Association U.S. Department of Commerce, Patent and Trademark Office U.S. Environmental Protection Agency. Massachusetts Institute of Technology National Agricultural Chemicals Association American Chemical Society Health Industry Manufacturers Association Zenith Laboratories, Inc....... Public Citizen Health Research Group Page 250 251 252 253 254 255 256 257 257 259 260 National Retired Teachers Association and American Association of Retired 281 The Institute of Electrical and Electronics Engineers, Inc.. 300 National Agricultural Chemicals Association.. Society of University Patent Administrators Mobil Oil Corp 301 303 304 |